This is one of the few trials in gastric cancer that has been significantly positive for all the efficacy parameters.

—Hansjochen Wilke, MD

In the global phase III RAINBOW trial in patients with metastatic gastric cancer, the investigational monoclonal antibody ramucirumab significantly improved both progression-free and overall survival, when added to paclitaxel in second-line therapy, as reported at the 2014 Gastrointestinal Cancers Symposium.1

Dr. Wilke noted that patients with disease progression after first-line treatment usually had a median survival of only about 3 months with best supportive care, and only about one-third of patients in the Western world receive second-line therapy. RAINBOW is the largest clinical trial of second-line therapy in this patient population to date.

RAINBOW Details

This randomized, double-blind, placebo-controlled study included 665 patients with metastatic gastroesophageal junction or gastric adenocarcinoma who had disease progression while on or within 4 months after a standard first-line platinum- and fluoropyrimidine-based combination chemotherapy. They were randomly assigned to receive paclitaxel alone (80 mg/ m2 on days 1, 8, 15) or with ramucirumab (8 mg/ kg IV every 2 weeks) in 4-week cycles until progression or intolerable toxicity. The primary endpoint was overall survival.

“Neutropenia was more frequently reported in the ramucirumab/paclitaxel arm, but the incidence of febrile neutropenia was comparable [3.1% vs 2.4%],” Dr. Wilke said. “Adverse events did not lead to a higher discontinuation rate, which was 11% in each arm.” ■

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Manish Shah, MD, Director of Gastrointestinal Oncology and Associate Professor of Medicine at New York–Presbyterian/Weill Cornell Medical Center in New York, discussed the findings of the RAINBOW trial at the 2014 Gastrointestinal Cancers Symposium.